Neuromuscular Electrical Stimulation in Acute Ischemic Stroke

NCT03653312 | Unknown DMC

• 1 other identifier: REG-80-2015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine the added effect of NeuroMuscular Electric Stimulation (NMES) in addition to exercise therapy in the acute phase of ischemic stroke. This randomized controlled trial includes 50 patients allocated to either control or intervention. The inclusion, test, training and re-test will be provided during the first 14 days after ictus, starting day 1 or 2 after ictus and a follow-up at day 90. The exercise training with external NMES is done with the patient every weekday for 12 minutes.

Conditions

Ischemic Stroke; Neuromuscular Electrical Stimulation; Exercise

Keywords

Ischemic Stroke; Neuromuscular electrical stimulation; Activities of daily living; Patient reported outcome; Fugl Meyer

Outcome Measures

Primary Outcomes (1)

• The six Minute-Walk Test

  The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

  Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.

Secondary Outcomes (8)

• Fugl Meyer Assessment

  Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.

• Sit to stand

  Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.

• Timed Up and Go

  Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.

• EuroQOL 5 domain

  Change from day 14 post ictus to day 90 post ictus.

• 10 meter walk test

  Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.

Study Arms (2)

NMES

ACTIVE COMPARATOR

2 weeks (weekdays) of Neuromuscular Electrical Stimulation of the paretic lower limb during exercise. Each exercise session will last for 12 minutes and will consist of either walk or sit and raise from a chair.

Device: NMES

training

NO INTERVENTION

Participants will undergo 2 weeks of exercise every weekday. Each exercise session will last for 12 minutes and will consist of either walk or sit and raise from a chair.

Interventions

NMES DEVICE

Neuromuscular electrical stimulation of the paretic lower limb during exercise

NMES

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic apoplexy and paresis in lower extremity, verified with picture diagnosis (CT/MR) or clinically diagnosed.
• Leg palsy equalizes 2-4
• Modified Ranking Scale(mRS) =0-1
• Cognitive function adequate to participate

You may not qualify if:

• Patients with dementia and/or malign diseases
• Pregnancy
• Epilepsy
• Total loss of sensation
• Pacemaker
• Previous or current blood clot in the leg
• Untreated depression
• Untreated alcohol or drug abuse
• Untreated hypertension
• Heart disease which limits function

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Neurology

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Ischemic Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Troels Wienecke, MD, PhD

  Department of Neurology, Zealand University Hospital, University of Copenhagen, Roskilde, Denmark

  STUDY DIRECTOR

• Henriette Busk, PT

  Dept. of Neurology, Zealand University Hospital, and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospital, Copenhagen University

  PRINCIPAL INVESTIGATOR

• Søren T Skou, PT, PhD

  University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals

  STUDY CHAIR

• Gert Kwakkel

  Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, The Netherlands

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One blinded outcome assessor (physiotherapists) will perform measurements of functional capacity, patient reported outcome, and cognition. Statistical analysis will be performed by a blinded statistician and a blinded interpretation of the results will be performed before breaking the randomization code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group, assessor blinded, randomized controlled trial

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: August 27, 2018
• Primary Completion: June 3, 2020
• Study Completion: December 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

DK (1)